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Trumenba is a brand name for Meningococcal Group B Vaccine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B. See section 5.1 for information on the immune response against specific serogroup B strains. The use of this vaccine should be in accordance with…
Verbatim from this product's EMA label. Tap a section to expand.
1). 1). 1). Other paediatric populations Safety and efficacy of Trumenba in children younger than 10 years of age have not been established. 1; however, no recommendation on a posology can be made as data are limited. 8). Method of administration For intramuscular injection only.
The preferred site for injection is the deltoid muscle of the upper arm. 6. There are no data available on the interchangeability of Trumenba with other meningococcal group B vaccines to complete the vaccination series.
Summary of the safety profile The safety profile presented is based on analysis of approximately 17,000 subjects (1 year of age and older) who have been vaccinated with at least 1 dose of Trumenba in completed clinical studies. In over 16,000 subjects ≥ 10 years of age studied, the most common adverse reactions were headache, diarrhoea, nausea, muscle pain, joint pain, fatigue, chills, and injection site pain, swelling and redness.
Adverse reactions following booster vaccination in 301 subjects 15 to 23 years of age were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier. List of adverse reactions Adverse reactions reported in clinical studies of subjects 10 years of age and older are listed in decreasing order of frequency and seriousness.
Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from available data) Immune system disorders Not known: Allergic reactions* Nervous system disorders Very Common: Headache Gastrointestinal disorders Very Common: Diarrhoea; nausea Common: Vomiting Musculoskeletal and connective tissue disorders Very Common: Muscle pain (myalgia); joint pain (arthralgia) 6 General disorders and administration site conditions Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site Common: Fever ≥ 38 °C (pyrexia) *Reported in the postmarketing experience.
Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known. Paediatric population < 10 years of age Children/toddlers In a study of 294 children 2 to 9 years of age, the following adverse reactions occurred at a frequency of very common (≥ 1/10): headache, diarrhoea, vomiting, muscle pain, joint pain, fever, fatigue, and injection site pain, swelling and redness.
Traceability In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded. Hypersensitivity Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Syncope As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba. Procedures should be in place to avoid injury from fainting. Concurrent acute illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness.
However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination. Intramuscular injections Trumenba should not be administered intravenously, intradermally, or subcutaneously. 4 Trumenba should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.
Altered immunocompetence Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba. 1). Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop antibodies following vaccination with Trumenba.
Protection against meningococcal disease As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients. Limitations of clinical trials There are limited data on the use of Trumenba in individuals 40 to 65 years of age and there are no data on the use of Trumenba in individuals older than 65 years of age.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5% of subjects. In a study of 220 toddlers 1 to < 2 years of age, the following adverse reactions occurred at a frequency of very common (≥ 1/10): drowsiness, irritability (fussiness), loss of or decreased appetite, fever, and injection site pain, swelling and redness.
3% of subjects. In clinical studies, fever (≥ 38 °C) occurred more frequently as subject age decreased. Fever followed a predictable pattern after vaccination: onset occurred within 2 to 4 days, lasted 1 day, and was mild to moderate in severity.
Fever rate and severity tended to decrease with subsequent Trumenba vaccinations. Booster vaccination in children Adverse reactions following a booster vaccination in 147 subjects 3 to 5 years of age were similar to adverse reactions during the primary Trumenba vaccination series approximately 2 years earlier.
Infants less than 1 year of age In a study including 115 infants 2 months and 48 infants 6 months of age who received Trumenba or an investigational combination meningococcal vaccine containing Trumenba co-administered with vaccines licensed for this age group, the following adverse reactions occurred at a frequency of very common (≥ 1/10): drowsiness, irritability (fussiness), loss of or decreased appetite, fever, and injection site pain, swelling and redness.
Fever (≥ 38 °C) was reported in 74% of subjects, with 69% of subjects (33 out of 48) 6 months of age reporting fever and 76% of subjects (87 out of 115) 2 months of age. 0%) in both age groups, despite the use of paracetamol. The rate and severity of fever did not decrease with the second vaccination in the youngest infants.
3 °C and 39 °C, respectively) after the first vaccination that, despite the use of antipyretics, led to medical attention and investigations including lumbar puncture. Cerebrospinal fluid (CSF) analysis showed pleocytosis without positive microbiological test results in 1 infant.
Both cases were treated as presumed infections. Symptoms resolved for both infants. Postmarketing data revealed 3 additional cases in which infants 1 to 3 months of age experienced fever leading to medical attention and investigations including lumbar puncture 1 day after administration of Trumenba.
CSF analysis showed no pleocytosis in 2 cases and in 1 case showed pleocytosis without a positive microbiological test result. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 7
Excipients This vaccine contains polysorbate 80 (see section 2). Polysorbate 80 may cause hypersensitivity reactions. This vaccine contains less than 1 mmol sodium (23 mg) per dose. Individuals on low sodium diets can be informed that this vaccine is essentially sodium-free.